CN103252013B - Puncturing sheath for aortic vessel lumen interventional surgery - Google Patents
Puncturing sheath for aortic vessel lumen interventional surgery Download PDFInfo
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- CN103252013B CN103252013B CN201310220108.7A CN201310220108A CN103252013B CN 103252013 B CN103252013 B CN 103252013B CN 201310220108 A CN201310220108 A CN 201310220108A CN 103252013 B CN103252013 B CN 103252013B
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- 238000001356 surgical procedure Methods 0.000 title abstract description 16
- 239000012528 membrane Substances 0.000 claims abstract description 7
- 239000008280 blood Substances 0.000 claims abstract description 6
- 210000004369 blood Anatomy 0.000 claims abstract description 6
- 239000004816 latex Substances 0.000 claims description 4
- 229920000126 latex Polymers 0.000 claims description 4
- 238000004806 packaging method and process Methods 0.000 claims 1
- 230000007306 turnover Effects 0.000 claims 1
- 210000001367 artery Anatomy 0.000 abstract description 2
- 239000011148 porous material Substances 0.000 abstract 1
- 230000002792 vascular Effects 0.000 description 15
- 210000004204 blood vessel Anatomy 0.000 description 13
- 238000001802 infusion Methods 0.000 description 11
- 210000001105 femoral artery Anatomy 0.000 description 7
- 238000004140 cleaning Methods 0.000 description 5
- 238000007789 sealing Methods 0.000 description 5
- 230000000903 blocking effect Effects 0.000 description 4
- 208000032843 Hemorrhage Diseases 0.000 description 3
- 208000034158 bleeding Diseases 0.000 description 3
- 230000000740 bleeding effect Effects 0.000 description 3
- 230000002439 hemostatic effect Effects 0.000 description 3
- 239000007788 liquid Substances 0.000 description 3
- 238000000034 method Methods 0.000 description 3
- 208000007536 Thrombosis Diseases 0.000 description 2
- 206010057469 Vascular stenosis Diseases 0.000 description 2
- 238000002347 injection Methods 0.000 description 2
- 239000007924 injection Substances 0.000 description 2
- 208000028867 ischemia Diseases 0.000 description 2
- 230000003902 lesion Effects 0.000 description 2
- 210000003141 lower extremity Anatomy 0.000 description 2
- 230000002980 postoperative effect Effects 0.000 description 2
- 208000025494 Aortic disease Diseases 0.000 description 1
- 206010071229 Procedural haemorrhage Diseases 0.000 description 1
- 210000000709 aorta Anatomy 0.000 description 1
- 239000002473 artificial blood Substances 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000036772 blood pressure Effects 0.000 description 1
- 239000002131 composite material Substances 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 230000003631 expected effect Effects 0.000 description 1
- 230000005669 field effect Effects 0.000 description 1
- 230000001788 irregular Effects 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 239000002861 polymer material Substances 0.000 description 1
- 229910001220 stainless steel Inorganic materials 0.000 description 1
- 239000010935 stainless steel Substances 0.000 description 1
- 230000009182 swimming Effects 0.000 description 1
- 230000000007 visual effect Effects 0.000 description 1
- 238000004804 winding Methods 0.000 description 1
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Abstract
Description
技术领域technical field
本发明涉及一种用于介入手术器械,涉及主动脉血管腔介入手术穿刺鞘;尤其是一种带内封堵球囊的大尺寸血管穿刺鞘。The invention relates to an instrument for interventional surgery, in particular to a puncture sheath for aortic vessel cavity interventional surgery; in particular, a large-size blood vessel puncture sheath with an internal blocking balloon.
背景技术Background technique
主动脉腔内修复术为目前各种主动脉疾病治疗的发展方向,随着介入技术、器材的发展,主动脉血管腔内治疗已经取代传统开放手术,成为主流手术方式。Endovascular aortic repair is the current development direction for the treatment of various aortic diseases. With the development of interventional technology and equipment, endovascular aortic repair has replaced traditional open surgery and has become the mainstream surgical method.
主动脉腔内手术,与普通血管介入手术不同,由于主动脉支架输送系统较粗(一般大于20F),一般不使用血管穿刺鞘,而是取腹股沟切口,暴露股动脉,横行切开股动脉,引入导丝导管定位后,直接从股动脉切口置入支架输送系统,将支架放置在病变部位释放。但是,该种方法无血管穿刺鞘保护血管,使得术中出血不易控制。而且,支架输送鞘与股动脉直接接触,摩擦较多,使得支架输送困难,同时,会损伤血管内膜,造成术中血管缝合困难,易造成术后血管狭窄,血栓形成,下肢动脉缺血等并发症。Endovascular aortic surgery is different from common vascular interventional surgery. Because the aortic stent delivery system is relatively thick (generally greater than 20F), the vascular puncture sheath is generally not used. Instead, an inguinal incision is made to expose the femoral artery and the femoral artery is cut transversely. After the introduction of the guide wire catheter for positioning, the stent delivery system is directly inserted into the femoral artery incision, and the stent is placed at the lesion and released. However, in this method, there is no vascular puncture sheath to protect the blood vessels, which makes it difficult to control bleeding during the operation. Moreover, the stent delivery sheath is in direct contact with the femoral artery, causing more friction, making stent delivery difficult. At the same time, it will damage the intima of the vessel, making it difficult to suture the vessel during the operation, and easily causing postoperative vascular stenosis, thrombosis, and lower extremity arterial ischemia. complication.
临床的常用的穿刺鞘大多在10F以下,用于中小血管介入手术。用于大血管介入手术的大型血管鞘几乎未见,少数的临床使用的血管鞘,效果不佳,封闭不严密,易漏血等缺陷,偶有带封堵系统的血管鞘,结构复杂,使用不便,同时仍存在较大出血风险。Most of the commonly used clinical puncture sheaths are below 10F and are used for small and medium blood vessel interventional operations. There are almost no large vascular sheaths used for interventional surgery of large blood vessels. A few clinically used vascular sheaths are not effective, not tightly sealed, and prone to blood leakage. Occasionally, vascular sheaths with a sealing system have complex structures. Inconvenient, but there is still a greater risk of bleeding.
目前,尚未有简单易用的带堵血功能的大型血管鞘出现,使术者有力不从心的感觉,影响手术的操作和手术质量。At present, there is no easy-to-use large-scale vascular sheath with blood blocking function, which makes the operator feel powerless and affects the operation and operation quality of the operation.
本申请人提出的CN201210020329带球囊的血管穿刺封堵鞘,球囊位于血管穿刺封堵鞘的外径,用于人工血管旁路转流手术使用的带可充液(气)球囊的血管穿刺封堵鞘,用于保证在人工血管上操作等手术操作时的良好视野和止血效果;但不适用于主动脉腔内修复术。主动脉血管腔内修复术最需要大尺寸血管穿刺鞘,具有极好的穿刺鞘内止血装置,现有的10F以下穿刺鞘内止血装置只是穿刺鞘未端的一层弹性膜,承受不了大直径时(5-9mm)血压。The applicant proposes CN201210020329 vascular puncture occlusion sheath with balloon, the balloon is located on the outer diameter of the vascular puncture occlusion sheath, and is used for blood vessels with inflatable (air) balloons used in artificial vascular bypass surgery The puncture blocking sheath is used to ensure good visual field and hemostatic effect when operating on artificial blood vessels and other operations; but it is not suitable for endovascular repair of aorta. Endovascular repair of aortic vessels most requires a large-sized vascular puncture sheath with an excellent puncture sheath hemostatic device. The existing puncture sheath hemostatic device below 10F is only a layer of elastic membrane at the end of the puncture sheath, which cannot withstand large diameters. (5-9mm) blood pressure.
发明内容Contents of the invention
本发明目的是:提出一种带堵血气囊的大口径血管穿刺鞘,通过气囊的设计和充气装置的设计,使本发明可用于主动脉腔内手术,大口径血管穿刺鞘使所有手术操作时都位于血管内(典型的是支架输送并安放),便于手术操作,手术可靠;本发明目的还在于提出一种清洗管出口位置置于前端的血管穿刺鞘,更有效的与本发明配合。The purpose of the invention is to: propose a large-diameter blood vessel puncture sheath with a blood-blocking air bag, through the design of the air bag and the design of the inflation device, the present invention can be used for aortic intracavitary surgery, and the large-diameter blood vessel puncture sheath can make all surgical operations They are all located in the blood vessel (typically stent delivery and placement), which is convenient for operation and reliable in operation; the purpose of the present invention is also to propose a vascular puncture sheath with the outlet of the cleaning tube placed at the front end, which is more effective in cooperation with the present invention.
本发明技术方案是:主动脉血管腔介入手术穿刺鞘,包括鞘管1、鞘柄5,鞘管1内壁置有充气后堵塞鞘管1内壁的环形气囊7,环形气囊7的中央具有弹性包裹进出器械的孔道。The technical scheme of the present invention is: a puncture sheath for interventional surgery in the aortic vessel cavity, comprising a sheath tube 1 and a sheath handle 5, the inner wall of the sheath tube 1 is provided with an annular air bag 7 that blocks the inner wall of the sheath tube 1 after inflation, and the center of the annular air bag 7 has an elastic package The hole for entering and exiting the instrument.
进一步的,环形气囊7通过气囊导管9连接充气装置8。Further, the annular airbag 7 is connected to the inflation device 8 through the airbag catheter 9 .
进一步的,充气装置8上设有充气锁定装置8-1。Further, the inflatable device 8 is provided with an inflatable locking device 8-1.
进一步的,鞘管1内输液管的出口3、内输液管4、外输液管6、环形气囊7、充气装置8、充气锁定装置8-1、气囊导管9、Further, the outlet 3 of the infusion tube in the sheath tube 1, the inner infusion tube 4, the outer infusion tube 6, the annular air bag 7, the inflation device 8, the inflation locking device 8-1, the balloon catheter 9,
进一步的,环形气囊7由管状气囊7绕制成环形气囊的结构,绕制成环形气囊具有叠边10;乳胶的边叠成的中央膜11。Further, the annular airbag 7 is formed by winding the tubular airbag 7 into an annular airbag structure, and the annular airbag has folded edges 10; the central film 11 is formed by overlapping the latex edges.
环形气囊7通过气囊导管连接头12与气囊导管9连接,气囊导管9可以置于鞘管1外部或者为鞘管的内腔。The annular balloon 7 is connected to the balloon catheter 9 through the balloon catheter connector 12, and the balloon catheter 9 can be placed outside the sheath tube 1 or be the inner cavity of the sheath tube.
进一步的,鞘管1的内腔设有内输液管,内输液管的出口3位于环形气囊位置的前端,内输液管的从鞘柄5连接。Further, the inner cavity of the sheath tube 1 is provided with an inner infusion tube, the outlet 3 of the inner infusion tube is located at the front end of the annular air bag, and the inner infusion tube is connected from the sheath handle 5 .
本发明穿刺鞘的管径尤其是14F以上,甚至24F,便于制备成含输液管的多腔管。The pipe diameter of the puncture sheath of the present invention is more than 14F, even 24F, which is convenient to be prepared as a multi-lumen tube containing an infusion tube.
本发明有益效果是:通过气囊和充气装置的匹配,使手术器械方便可以通过气囊中央的膜孔,气囊又可以承受动脉的压力,保证不漏出血。给主动脉腔内手术提供一种方便的器械,便于手术操作,手术可靠;清洗或注射药液管出口位置置于血管穿刺鞘前端,也是方便手术中的注药或清洗(清洗时可略松开气囊)。本发明典型的用于主动脉血管腔介入手术,通过横行切开股动脉,引入导丝导管定位后,直接从股动脉切口置入支架输送系统,将支架放置在病变部位释放。本发明通过血管穿刺鞘保护血管,术中出血易控制。而且,支架输送鞘与股动脉不直接接触,支架输送容易,不会损伤血管内膜,不易造成术后血管狭窄,血栓形成,下肢动脉缺血等并发症。本发明带内封堵球囊的大尺寸血管穿刺鞘在手术中试用效果良好,达到了预期效果。The beneficial effects of the invention are: through the matching of the air bag and the inflatable device, the surgical instrument can conveniently pass through the membrane hole in the center of the air bag, and the air bag can withstand the pressure of the artery to ensure no bleeding. Provide a convenient instrument for intra-aortic surgery, which is convenient for operation and reliable in operation; the outlet of the cleaning or injection liquid tube is placed at the front of the vascular puncture sheath, which is also convenient for injection or cleaning during the operation (it can be slightly loosened during cleaning) open the airbag). The present invention is typically used for interventional surgery of the aortic vessel cavity. The femoral artery is cut transversely, and after the guide wire catheter is introduced for positioning, the stent delivery system is directly inserted into the femoral artery incision, and the stent is placed on the lesion site for release. The invention protects the blood vessel through the blood vessel puncture sheath, and the intraoperative bleeding is easy to control. Moreover, the stent delivery sheath is not in direct contact with the femoral artery, and the stent delivery is easy without damaging the intima of the blood vessel, and it is not easy to cause complications such as postoperative vascular stenosis, thrombosis, and lower extremity arterial ischemia. The large-size blood vessel puncture sheath with the inner blocking balloon of the present invention has a good trial effect in operation and has achieved the expected effect.
附图说明Description of drawings
图1是本发明结构示意图;Fig. 1 is a structural representation of the present invention;
图2是环形气囊结构示意图。Fig. 2 is a schematic diagram of the structure of the annular airbag.
具体实施方式Detailed ways
如图1-2所示,鞘管1、输液管内径2、鞘柄5,内输液管的出口3、内输液管4、外输液管6、环形气囊7、充气装置8、充气锁定装置8-1、气囊导管9、叠边10、中央膜11、气囊导管连接头12。鞘管采用不锈钢或硬质高分子材料,球囊采用乳胶或弹性的橡塑复合材料。As shown in Figure 1-2, the sheath tube 1, the inner diameter of the infusion tube 2, the sheath handle 5, the outlet of the inner infusion tube 3, the inner infusion tube 4, the outer infusion tube 6, the annular air bag 7, the inflation device 8, and the inflation locking device 8 -1. Balloon catheter 9 , folded edge 10 , central membrane 11 , balloon catheter connector 12 . The sheath tube is made of stainless steel or hard polymer material, and the balloon is made of latex or elastic rubber-plastic composite material.
本发明在传统的血管穿刺鞘的鞘管内置有环形气囊7,环形气囊7由乳胶制备,通过连接充气装置8(可为机械泵提供正压的任何气源,也可为手动注射器)、充气锁定装置8-1可以是正压气源管道的截止阀,也可以是针筒的抽芯固定装置。In the present invention, an annular air bag 7 is built in the sheath tube of the traditional vascular puncture sheath. The annular air bag 7 is made of latex, and is inflated by connecting the inflation device 8 (any air source that can provide positive pressure for a mechanical pump, or a manual syringe). The locking device 8-1 can be a shut-off valve of the positive pressure air source pipeline, or a core-pulling fixing device of the syringe.
环形气囊7也可以是不规则的形状,如管状气囊7绕制成环形气囊的结构中,可以在管状气囊7搭接处设有进出器械(具有密封包裹、弹性密封的功能)的通道。也可以是类似游泳圈的结构,但中央有封闭膜(具有密封包裹、弹性密封的功能),可以供器械进入并封闭。The annular airbag 7 can also be of irregular shape. For example, in the structure in which the tubular airbag 7 is wound into an annular airbag, passages for entering and exiting instruments (with the functions of sealing wrapping and elastic sealing) can be provided at the overlap of the tubular airbags 7 . It can also be a structure similar to a swimming ring, but there is a closed membrane in the center (with the function of airtight wrapping and elastic sealing), which can be used for the entry and closure of instruments.
本发明血管鞘在进行手术时,鞘管在需要注射药液或清洗液时,均可以调节密封的程度。When the vascular sheath of the present invention is performing an operation, the degree of sealing can be adjusted when the sheath tube needs to inject medicinal liquid or cleaning liquid.
环形气囊通过气囊导管连接头与气囊导管连接,气囊导管置于鞘1外部或者为鞘管的内腔。The annular balloon is connected with the balloon catheter through the balloon catheter connector, and the balloon catheter is placed outside the sheath 1 or is the inner cavity of the sheath.
本发明的实施例并没有限定本发明,任何基于本发明的简单改进并没有超出本发明要求保护的范围。The embodiments of the present invention do not limit the present invention, and any simple improvement based on the present invention does not exceed the protection scope of the present invention.
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CN201310220108.7A CN103252013B (en) | 2013-06-04 | 2013-06-04 | Puncturing sheath for aortic vessel lumen interventional surgery |
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CN110772305B (en) * | 2019-11-22 | 2021-08-13 | 温州医科大学附属第一医院 | Puncture outfit for laparoscopic surgery |
CN112190334B (en) * | 2020-10-22 | 2022-02-18 | 北京唯迈医疗设备有限公司 | Convenient sterile intervention auxiliary operation robot |
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US4884573A (en) * | 1988-03-07 | 1989-12-05 | Leocor, Inc. | Very low profile angioplasty balloon catheter with capacity to use steerable, removable guidewire |
US7226464B2 (en) * | 2001-03-01 | 2007-06-05 | Scimed Life Systems, Inc. | Intravascular filter retrieval device having an actuatable dilator tip |
CN2649026Y (en) * | 2003-10-31 | 2004-10-20 | 张人美 | Retainable hydropericardium puncturing needle |
US8764820B2 (en) * | 2005-11-16 | 2014-07-01 | Edwards Lifesciences Corporation | Transapical heart valve delivery system and method |
CN100405981C (en) * | 2006-06-28 | 2008-07-30 | 金磊 | Occluder delivery system for cardiac surgery department |
CN100475166C (en) * | 2006-08-29 | 2009-04-08 | 浙江大学 | Internal support type interlayer gas bag venous blocking-up drainage tube |
WO2010029190A1 (en) * | 2008-09-15 | 2010-03-18 | Joensson Anders | Medical device, method and system for temporary occlusion of an opening in a lumen of a body |
US9192746B2 (en) * | 2010-06-07 | 2015-11-24 | Cook Medical Technologies Llc | Reperfusion catheter system |
CN102379731B (en) * | 2011-08-03 | 2014-02-19 | 北京华医圣杰科技有限公司 | Aortic aneurysm dissection stent system and preparation method thereof |
CN202289179U (en) * | 2011-08-12 | 2012-07-04 | 上海交通大学医学院附属第九人民医院 | Bidirectional conduit exchange sheath |
CN102551819B (en) * | 2012-01-29 | 2013-09-04 | 南京大学医学院附属鼓楼医院 | Blood vessel puncture plugging sheath with balloon |
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